1. Field of the Invention
The present invention concerns a method for treating or preventing bacterial vaginosis using cellulose acetate phthalate and/or hydroxypropyl methylcellulose phthalate.
2. Background Information
Recent findings suggest that bacterial vaginosis (xe2x80x9cBVxe2x80x9d) may increase susceptibility to HIV-1 infection (Sewankambo, EN., Gray R. H., Wawer et al., M. J., xe2x80x9cHIV-1 Infection Associated with Abnormal Vaginal Flora Morphology and Bacterial Vaginosisxe2x80x9d, Lancet, 350, 546-550, (1997); Taha, T. E., Hoover, D. R., Dallabeta et al., G. A., xe2x80x9cBacterial Vaginosis and Disturbances of Vaginal Flora: Association with Increased Acquisition of HIVxe2x80x9d, AIDS, 12, 1699-1706, (1998); Cohen, C. R., Duerr, A., Pruithithada et al., N., xe2x80x9cBacterial Vaginosis and HIV Seroprevalence Among Female Commercial Sex Workers in Chiang Mai, Thailandxe2x80x9d, AIDS, 9, 1093-1097, (1995)). Depending on the population studied, up to nearly 40% of selected groups may have BV (Sobel, J. D., xe2x80x9cVaginitisxe2x80x9d, New England J. Med., 337, 1896-1903, (1997)). Although unequivocal evidence that BV is a sexually transmitted disease is lacking (Carr, P. L., Felsenstein, D., Friedman, R. H., xe2x80x9cEvaluation and Management of Vaginitisxe2x80x9d, J. Gen. Intern. Med., 13, 335-346, (1998)), BV behaves in many ways as if it were a sexually transmitted disease (xe2x80x9cSTDxe2x80x9d) (Schwebke, J. R., xe2x80x9cBacterial Vaginosisxe2x80x94More Questions Than Answersxe2x80x9d [editorial], Genitourin Med., 73, 333-334, (1997)). Therefore, treatment of BV is expected to contribute to controlling the spread of STDs, including HIV-1 (Schwebke, J. R., xe2x80x9cBacterial Vaginosisxe2x80x94More Questions Than Answersxe2x80x9d [editorial], Genitourin Med., 73, 333-334, (1997)).
It has recently been reported that cellulose acetate phthalate (xe2x80x9cCAPxe2x80x9d) (Eastman Kingston, Tenn., USA) which has heretofore been used as an excipient for the enteric coating of tablets and capsules (Lee, J. C., (1994), Cellulose acetate phthalate, Handbook of Pharmaceutical Excipients, 2nd Ed., Wade, A. and Weller, P. J., pp. 91-93, American Pharmaceutical Association Publishers, Washington, D.C.), has antiviral activity in vitro against HIV-1 and herpesviruses (xe2x80x9cHSVxe2x80x9d) and, when appropriately formulated, inactivated HIV-1, herpesviruses and several bacterial STD pathogens without affecting Lactobacilli (Neurath, A. R., Strick, N., Li, Y-Y, Jiang, S., xe2x80x9cDesign of a xe2x80x98Microbicidexe2x80x99 for Prevention of Sexually Transmitted Diseases Using xe2x80x98Inactivexe2x80x99 Pharmaceutical Excipientsxe2x80x9d, Biologicals, 27, 11-21, (1999)), essential for maintaining a normal vaginal flora (Martin, Jr., H. L., Richardson, B. A., Nyange, P., Lavreys, L., Hiller, S. L., Chohan, B. et al. (1999), xe2x80x9cVaginal Lactobacilli, Microbial Flora, and Risk of Human Immunodeficiency Virus Type 1 and Sexually Transmitted Disease Acquisitionxe2x80x9d, Journal of Infectious Diseases, 180, 1863-1868), (Handbook of Pharmaceutical Excipients), Wade, A. and Weller, P. J., eds., 2nd Ed., American Pharmaceutical Association, (1994); Klebanoff, S. J., Coombs, R. W., xe2x80x9cViricidal Effect of Lactobacillus Acidophilus on Human Immunodeficiency Virus Type 1: Possible Role in Heterosexual Transmissionxe2x80x9d, J. Exp. Med., 174, 289-292, (1991)). These findings have been further strengthened by the favorable outcome of experiments in the HSV-2/mouse (Gyotoku, T., Aurelian, L. and Neurath, A. R., xe2x80x9cCellulose Acetate Phthalate (CAP): An xe2x80x98Inactivexe2x80x99 Pharmaceutical Excipient with Antiviral Activity in the Mouse Model of Genital Herpesvirus Infectionxe2x80x9d, Antiviral Chemistry and Chemotherapy, 10, 327-332, (1999)) and simian immunodeficiency virus/monkey models for vaginal infection.
Considering the role of BV in susceptibility to infection by HIV-1 and other STD pathogens, it seemed important to the present inventor to also evaluate the effect of CAP on microorganisms associated with BV, namely, Gardnerella Vaginalis, Mycoplasmas, Mobiluncus curtisii and Prevotella corporis (Sobel, J. D., xe2x80x9cVaginitisxe2x80x9d, New England J. Med., 337, 1896-1903, (1997); Schwebke, J. R., xe2x80x9cBacterial Vaginosisxe2x80x94More Questions Than Answersxe2x80x9d [editorial], Genitourin Med., 73, 333-334, (1997); Hill, G. B., xe2x80x9cThe Microbiology of Bacterial Vaginosisxe2x80x9d, Am. J. Obstet. Gynecol., 169, 450-454, (1993)).
Heretofore uses of CAP are described in U.S. Pat. No. 5,985,313 and U.S. application Ser. No. 09/175,909.
It is an object of the present invention to provide a method for treating and preventing bacterial vaginosis.
The present invention concerns a method for treating or preventing bacterial vaginosis comprising administering to a human female an effective anti-bacterial vaginosis amount of a composition comprising at least one active compound selected from the group consisting of cellulose acetate phthalate and hydroxypropyl methylcellulose phthalate, either alone or in combination with a pharmaceutically acceptable carrier.